Social Determinants of Health HCC Trial
A Randomized Controlled Interventional Trial of a Social Determinants of Health and Patient Navigation Program to Improve Treatment Utilization Among Low-income Patients With Hepatocellular Carcinoma
研究概览
详细说明
Social determinants of health (SDOH) play a central role in drop-offs at each step of the cancer care cascade for patients living in poverty. Social barriers have been shown to result in delays in care, increased non-compliance, and poorer outcomes. Importantly, negative SDOH among patients with HCC may impact receipt of therapy, a critical contributor to improved survival. Studies have shown that even small delays in therapy (more than 3 months from diagnosis) can lead to worse survival. The treatment landscape for HCC is complex, ranging from surgical options to locoregional therapies to immunotherapy, and requires multidisciplinary input from hepatologists, oncologists, interventional radiologists, and surgeons and frequent touchpoints with the healthcare system to successfully complete treatment. Social barriers can make navigating these complexities especially challenging for resource-poor patients with HCC.
The investigators hypothesize that intervening upon key social determinants of health along with patient navigation will lead to improvements in adherence to care and timely receipt of guideline-concordant treatment among underserved patients with HCC. Specifically, the study targets three modifiable and inter-related social barriers - unreliable transportation, housing instability, and food insecurity - that have previously been shown to be prevalent among patients with cirrhosis.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Kali Zhou
- 电话号码：323-452-2293
- 邮箱：kali.zhou@med.usc.edu
学习地点
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California
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Los Angeles、California、美国、90033
- USC Norris Comprehensive Cancer Center
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接触：
- Christopher Wong Research Coordinator
- 电话号码：323-452-2293
- 邮箱：christophe.wong@med.usc.edu
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Los Angeles、California、美国、90033
- Keck Hospital of USC
-
接触：
- Christopher Wong Research Coordinator
- 电话号码：323-452-2293
- 邮箱：christophe.wong@med.usc.edu
-
Los Angeles、California、美国、90033
- LA General Medical Center
-
接触：
- Christopher Wong Research Coordinator
- 电话号码：323-452-2293
- 邮箱：christophe.wong@med.usc.edu
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Adults (18 years or older)
- Diagnosis of HCC (BCLC Stage A-C)
- Uninsured or underinsured (i.e., Medicaid as primary or secondary insurance)
- Able to provide informed consent
Exclusion Criteria:
- Non-HCC liver tumors
- BCLC Stage D and/or Child Pugh C cirrhosis (latter unable to receive treatment due to poor liver function)
- No plans for cancer treatment for any reason including patient refusal (best supportive care only)
- Only oral systemic therapy planned (i.e., tyrosine kinase inhibitors)
- Incarcerated patients or pregnant patients
- Unable to provide informed consent
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：SDOH and patient navigation program
Transportation support through Lyft rideshares, housing support through Hyatt House LA - University Medical Center, and meal support through Project Angel Food LA
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Social resources to be offered under our SDOH program will include 1) rideshares to treatment-related visits, 2) hotel stays for treatment-related visits, and/or 3) a 12-week meal delivery program.
Usual clinic-provided patient navigation to appointments, scheduling, social resources, financial challenges, etc.
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有源比较器：Patient navigation only
For the duration of the intervention, patients will have access to patient navigation as per usual care.
The intensity and frequency of navigation is dependent on the treating clinic; the provider of navigation (whether nurse vs social worker) is also variable by clinic.
This includes: coordination of care including assistance with scheduling follow-up visits, labs, imaging, and procedures, help with filling out forms for insurance, FMLA or disability benefits, facilitating communication with treating providers, referral to community and patient support groups, providing patients with educational materials and resources, check-ins on well-being and any cancer- or treatment-related concerns
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Usual clinic-provided patient navigation to appointments, scheduling, social resources, financial challenges, etc.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Proportion of participants with treatment uptake within 90 days
大体时间：90 days
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The primary outcome is receipt of timely treatment for HCC defined as within 90 days of randomization
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90 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Proportion receiving treatment
大体时间：2 years
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The secondary endpoint will evaluate the proportion of participants receiving treatment at any timepoint after randomization until end of study
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2 years
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Number of acute care visits
大体时间：2 years
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Utilization of acute care settings such as emergency room visits or hospital admissions during the study period
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2 years
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Patient-reported outcome - FACIT-COST Survey
大体时间：6 months
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Differences in financial toxicity as measured by the COST: A FACIT Measure of Financial Toxicity (FACIT-COST) Survey at the end of the intervention period (range 0-48; higher score means better financial well-being)
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6 months
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Patient reported outcome - FACT-HEP Survey
大体时间：6 months
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Comparison of difference in health-related quality of life based on the Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-HEP) Survey score (range 0-180; higher score means better quality of life)
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6 months
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Mortality
大体时间：2 years
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Proportion of participants who are alive at end of study period
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2 years
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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